The Supplement consists of one Editorial, three Commentaries and eleven Research Reports.
The objectivity of the articles differs substantially; one of the Commentaries could be classified as puffery and elements of the Editorial are on the edge. CRE has not reviewed the Research Reports in detail, but CRE has reviewed the most significant initiation/cessation studies identified by FDA.
With respect to the Supplement CRE concludes that the Editorial and Commentaries are merely hearsay and have no place for consideration in a scientific proceeding such as TPSAC.
Based upon CRE’s initial analysis it appears that virtually all of the research reports are a re-review of existing clinical studies. However, there are several conclusions of note:
“The finding that the longer the delay of smoking initiation, the more likely an individual smoked menthol cigarettes, does not support the notion that menthol promotes early smoking initiation.”
“After controlling for sex, age and race, the mean number of cigarettes smoked per day by current smokers is significantly lower for menthol smokers when compared to non-menthol smokers (odds ratio = 0.99; 95%).”
“After controlling for the covariates in each multivariate model, the differences between menthol and non-menthol smokers were no longer statistically significant, for smokers consuming fewer than five or six to 10 cigarettes per day” (Editor’s Note: time to first cigarette.)
“The findings that menthol smokers in the U.S. tend to start smoking later than smokers of other types of cigarettes are suggestive only and require further study.”
“Among African Americans those who currently smoked mentholated cigarettes were more likely [to] be seriously considering quitting in the next six months than were non-menthol smokers, after adjusting for sociodemographic factors. African Americans and Hispanics/Latinos who smoked mentholated cigarettes were also significantly more likely to have a positive estimation of successfully quitting in the next six months compared to non-menthol smokers.” (Editor’s Note: the odd ratios were removed from the text; consult the article for these data.)
The prominence given to the Editorial and the Commentaries relative to the Research Reports detracts from the overall use of the Supplement in a scientific proceeding
SOURCE Center for Regulatory Effectiveness